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A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus.

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Trial Profile

A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Empagliflozin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 01 Apr 2018 Results of post hoc analysis assessing changes in 24-h urine volume, fluid intake, and fluid balance in Japanese patients published in the Diabetes Therapy
    • 15 Sep 2017 Results of pooled analysis assessing safety of this and other phase I-III studies , presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
    • 15 Sep 2017 Results of pooled safety analysis in >12,000 patients who were randomized to Empagliflozin (10 mg, 25 mg) or placebo in 15 Phase I-III trials plus 4 extension studies, presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.

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